A CycLing and EducATion Intervention versus usual physiotherapy care for the treatment of hip osteoarthritis (CLEAT): A pragmatic randomised controlled trial of clinical and cost-effectiveness.

Abstract

Background. Osteoarthritis (OA) of the hip is a leading cause of chronic disability. The CLEAT trial compared the clinical and cost-effectiveness of CHAIN, a group-based cycling and education programme, with usual physiotherapy care for patients with hip OA referred for physiotherapy at a UK hospital. Methods. This pragmatic, single-centre randomised controlled trial randomised participants 1:1 to the 8-week CHAIN intervention or usual physiotherapy care. The primary outcome was the Hip Disability and Osteoarthritis Outcome Score (HOOS) Activities of Daily Living (ADL) subscale post-treatment. The trial included a parallel economic evaluation from the primary perspective of the UK NHS and personal social services. People with lived experience were involved in the design and management of the study. Trial registration: ISRCTN19778222. Findings. We recruited 221 participants and included in the analysis (126 females; mean age 64·4 (SD 9·54) years), 110 to CHAIN and 111 to usual physiotherapy care. CHAIN participants showed statistically significantly greater improvements in the HOOS ADL subscale post treatment (adjusted mean difference: 6·9 [95% CI 2·5 to 11·2, p=0·002]) compared to usual physiotherapy care. There were no treatmentrelated serious adverse events. CHAIN cost £4,092 per QALY gained compared to usual physiotherapy care, below the £20,000–£30,000 National Institute of Health and Care Excellence (NICE) threshold for cost-effectiveness. Interpretation. Post-treatment, CHAIN demonstrated superior outcomes compared to usual physiotherapy care, and the feasibility of delivering a low-cost, community-based intervention within the NHS was shown. However, longer-term benefits and broader generalisability warrant further investigation. Funding. The National Institute for Health and Care Research (NIHR) Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0816-20033).